PROVIGIL {modafinil} 200mg x28s Tablets
; "PROVIGIL {modafinil} 200mg x28s Tablets")
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Price: $185.00
Product ID : provigil_200mg
Manufacturer: LUNDBECK MX
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Description
Modafinil 100mg & 200mg Tablets
Pronunciation: (moe-DAF-i-nill)
Class: Analeptic
Trade Names:
- PROVIGIL
- ALERTEC (Canada)
- MODIODAL (Mexico)
Patient Education - English
- Generic Name: modafinil
- Pronounced: moe DAF i nil
- Brand Name: Provigil
What is the most important information I should know about modafinil?
You should not use this medication if you are allergic to modafinil or armodafanil (Nuvigil).
Before using modafinil, tell your doctor if you have angina (chest pain), liver or kidney disease, a heart problem, a history of drug addiction, if you take blood pressure medication, or if you have recently had a heart attack.
Modafinil affects the central nervous system. This can cause effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.
Stop taking modafinil and call your doctor if you have a skin rash, no matter how mild. A medicine similar to modafinil has caused severe skin reactions serious enough to require hospitalization. Other signs of a severe reaction include fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash.
There may be other drugs that can interact with modafinil. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
What is modafinil?
Modafinil is a medication that promotes wakefulness.
Modafinil is used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift work sleep disorder.
Modafinil may also be used for other purposes not listed in this medication guide.
What should I discuss with my health care provider before taking modafinil?
You should not use this medication if you are allergic to modafinil or armodafanil (Nuvigil).
If you have any of these other conditions, you may need a dose adjustment or special tests to safely take modafanil:
- angina (chest pain);
- cirrhosis or other liver problem;
- kidney disease;
- a heart muscle or valve disorder such as mitral valve prolapse;
- a history of drug addiction;
- if you take blood pressure medications; or
- if you have recently had a heart attack.
Skin rashes serious enough to require hospitalization have occurred in people using a medicine similar to modafinil. These rashes usually occurred within 1 to 5 weeks after the first dose.
Stop taking modafinil and call your doctor at the first sign of any skin rash, no matter how minor you think it might be.
FDA pregnancy category C. It is not known whether modafanil is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.
Modafinil can make certain types of birth control pills less effective, which could result in an unplanned pregnancy. Talk with your doctor about the best methods of birth control to use while taking modafinil.
It is not known whether modafinil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Do not give modafinil to anyone younger than 16 years old.
How should I take modafinil?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Modafinil is usually given for 12 weeks or less. Follow the directions on your prescription label.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Modafinil is usually taken each morning to prevent daytime sleepiness, or 1 hour before the start of a work shift to treat work-time sleep disorders.
If you are taking modafinil to treat sleepiness caused by obstructive sleep apnea, you may also be treated with a continuous positive airway pressure (CPAP) machine. This machine is an air pump connected to a mask that gently blows pressurized air into your nose while you sleep. The pump does not breathe for you, but the gentle force of air helps keep your airway open to prevent obstruction.
Do not stop using your CPAP machine during sleep unless your doctor tells you to. The combination of treatment with CPAP and modafinil may be necessary to best treat your condition.
Modafinil will not cure obstructive sleep apnea or treat its underlying causes. Follow your doctor's instructions about all your other treatments for this disorder.
Talk with your doctor if you continue to have excessive sleepiness even while taking modafinil.
Taking this medication does not take the place of getting enough sleep.
Store modafinil at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember, but avoid taking the medication if you do not plan to be awake for several hours. If it is close to your normal bedtime hour, you may need to skip the missed dose and wait until the next day to take the medicine again.
Talk with your doctor about what to do if you miss a dose of modafinil. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
Overdose symptoms may include feeling excited or agitated, confusion, trouble sleeping, nausea, or diarrhea.
What should I avoid while taking modafinil?
Modafinil affects the central nervous system. This can cause effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Avoid other dangerous activity until you know how this medication will affect your level of wakefulness.
Avoid drinking alcohol while taking modafinil.
What are the possible side effects of modafinil?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using modafinil and call your doctor at once if you have any of these serious side effects:
- fever, sore throat, headache, and vomiting with a severe blistering, peeling, and red skin rash;
- bruising, severe tingling, numbness, pain, muscle weakness;
- easy bruising or bleeding;
- white patches or sores inside your mouth or on your lips;
- hallucinations, unusual thoughts or behavior;
- depression, anxiety; or
- chest pain, uneven heart beats.
Less serious side effects may include:
- headache, dizziness;
- feeling nervous or agitated;
- nausea, diarrhea;
- trouble sleeping (insomnia); or
- dry mouth.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect modafinil?
Before using modafinil, tell your doctor if you are using any of the following drugs:
- cyclosporine (Neoral, Sandimmune, Gengraf);
- propranolol (Inderal);
- rifampin (Rifadin, Rimactane, Rifater);
- a sedative such as diazepam (Valium), midazolam (Versed), or triazolam (Halcion);
- antifungal medications such as itraconazole (Sporanox) or ketoconazole (Nizoral);
- seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), or phenobarbital (Luminal, Solfoton);
- antidepressants such as amitriptyline (Elavil, Etrafon), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others; or
- an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).
This list is not complete and there may be other drugs that can interact with modafinil. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
Where can I get more information?
Your pharmacist can provide more information about modafinil.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Pill Pictures
 Provigil (modafinil) 100 mg
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 Provigil (modafinil) 200 mg
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Pharmacology
Wakefulness-promoting agent; however, precise mechanism(s) unknown.
Pharmacokinetics
Absorption
T max is 2 to 4 h. Food delays T max approximately 1 h.
Distribution
Apparent Vd is 0.9 L/kg and protein binding is approximately 60%.
Metabolism
Primary site is hepatic via hydrolytic deamination, S-oxidation, aromatic ring hydroxylation, and glucuronide conjugation. Major inactive metabolites are modafinil acid and modafinil sulfone. Modafinil induces it own metabolism via CYP-450 3A4 after chronic administration.
Elimination
Approximately 80% (urine) and 1% (feces) are excreted in 11 days. The half-life is approximately 15 h.
Special Populations
Renal Function Impairment
Severe chronic renal failure (CrCl 20 mL/min or less) did not influence the pharmacokinetics, but exposure to modafinil was increased 9-fold.
Hepatic Function Impairment
In patients with severe hepatic function impairment, Cl is decreased approximately 60%, and steady-state concentrations are doubled. Dose reduction is recommended.
Elderly
Decrease of approximately 20% in oral Cl in patients with a mean age of 63 yr, which is not likely to be clinically important.
Indications and Usage
Improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSA/HS), and shift work sleep disorder (SWSD).
Unlabeled Uses
Treatment of fatigue associated with multiple sclerosis.
Contraindications
Hypersensitivity to armodafinil, modafinil, or any component of the product.
Dosage and Administration
Adults and Children (16 yr of age and older)
PO 200 mg/day as a single dose. Patients with narcolepsy or OSA/HS should take the dose in the morning, while patients with SWSD should take the dose 1 h prior to the start of work shift. Consider dosage adjustment for concomitant medications that are substrates for CYP3A4, such as triazolam and cyclosporine.
Elderly
Consider using a lower dose in this population.
Hepatic function impairment
A dose reduction of 50% is recommended.
Storage/Stability
Store tablets at 68° to 77°F.
Drug Interactions
Certain tricyclic antidepressants (eg, clomipramine, desipramine)
Plasma levels of certain tricyclic antidepressants may be increased.
Clomipramine
Plasma levels may be increased by modafinil.
Contraceptives, hormonal
Efficacy may be decreased by modafinil, increasing the risk of unintended pregnancy.
Cyclosporine
Blood levels may be decreased by modafinil.
CYP3A4 inducers (eg, carbemazepine, phenobarbital, rifampin) or inhibitors (eg, ketoconazole, itraconazole)
Coadministration could alter the plasma levels of modafinil.
Dextroamphetamine, methylphenidate
May delay the absorption of modafinil.
Drugs eliminated by CYP2C19 metabolism (eg, diazepam, phenytoin, propranolol)
May have prolonged elimination and may require dosage reduction, as well as monitoring for toxicity.
MAOIs (eg, isocarboxazid)
Use with caution.
Phenytoin
Increased risk of phenytoin toxicity.
Triazolam
Triazolam concentration may be decreased, reducing the clinical effect.
Warfarin
Monitor PT.
Laboratory Test Interactions
None well documented.
Adverse Reactions
Cardiovascular
Hypertension (3%); palpitation, tachycardia, vasodilatation (2%).
CNS
Headache (34%); nervousness (7%); anxiety, dizziness, insomnia (5%); depression, paresthesia, somnolence (2%); agitation, confusion, dyskinesia, emotional lability, hyperkinesia, hypertonia, tremor, vertigo (1%); delusions, hallucinations, mania, suicidal ideation (postmarketing).
Dermatologic
Herpes simplex, sweating (1%); serious rash including Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) (postmarketing).
EENT
Rhinitis (7%); pharyngitis (4%); abnormal vision, amblyopia, epistaxis, eye pain (1%).
GI
Nausea (11%); diarrhea (6%); dyspepsia (5%); anorexia, dry mouth (4%); constipation (2%); flatulence, mouth ulceration, taste perversion, thirst (1%).
Genitourinary
Hematuria, pyuria, urine abnormality (1%).
Hematologic-Lymphatic
Eosinophilia (1%); agranulocytosis (postmarketing).
Hepatic
Abnormal liver function (2%).
Hypersensitivity
Angioedema, hypersensitivity (with rash, dysphagia, and bronchospasm), multiorgan hypersensitivity with death (postmarketing).
Lab Tests
Increased gamma glutamyltransferase and alkaline phosphatase.
Metabolic-Nutritional
Edema (1%).
Musculoskeletal
Back pain (6%); neck rigidity (1%).
Respiratory
Lung disorder (2%); asthma (1%).
Miscellaneous
Flu-like syndrome (4%); chest pain (3%); chills (1%).
Precautions
MonitorMonitor for rash, or emergence or exacerbation of psychiatric symptoms. Consider monitoring BP. |
Pregnancy
Category C .
Lactation
Undetermined.
Children
Safety and efficacy in children younger than 16 yr of age not established.
Elderly
Safety and efficacy have not been established. Because elimination of modafinil and its metabolites may be reduced, consider using a lower dose.
Hepatic Function
Dosage reduction is recommended in patients with severe hepatic function impairment.
CNS
Psychotic episodes have been reported.
CV system
Not recommended for use in patients with history of left ventricular hypertrophy or mitral valve prolapse who have experienced the mitral valve prolapse syndrome when receiving CNS stimulants. Use with caution in patients with a recent history of MI or unstable angina.
Dermatologic reactions
Serious rash, which may be life-threatening or require hospitalization (eg, Stevens-Johnson syndrome, TEN), has been reported in postmarketing experience.
Drug dependence
Because of psychoactive and euphoric effects, modafinil has potential for abuse.
Hypersensitivity
Rarely, serious angioedema and hypersensitivity, with rash, dysphagia, and bronchospasm, have been reported. Multiorgan hypersensitivity (including 1 fatality) has been reported in postmarketing experience.
MI/Unstable angina
Use with caution.
Psychiatric symptoms
Psychiatric adverse reactions have been reported. Postmarketing adverse reactions have included delusions, hallucinations, mania, and suicidal ideation, some resulting in hospitalization.
Wakefulness
May not return to normal in patients taking modafinil.
Overdosage
Symptoms
Aggressiveness, agitation, anxiety, confusion, decreased PT, diarrhea, excitation, insomnia, irritability, nausea, nervousness, palpitations, sleep disturbances, slight to moderate elevations in hemodynamic parameters, tremor.
Patient Information
- Advise patient that medication will not cure sleep disorder and is not a replacement for sleep.
- Advise patient to read patient information leaflet before beginning therapy and to reread it each time medication is renewed.
- Advise patient that medication is taken only once a day.
- Advise patient using modafinil for narcolepsy or OSA/HS to take prescribed dose in the morning to minimize sleep disturbances.
- Advise patient using modafinil for SWSD to take prescribed dose 1 h prior to start of shift work.
- Advise patient to take each dose without regard to meals, but to take with food if stomach upset occurs.
- Advise patient to continue to take previously prescribed treatments (eg, continuous positive airway pressure for patient with OSA/HS) as instructed by health care provider.
- Caution patient not to alter previous behavior with regard to potentially dangerous activities (eg, driving, operating machinery) or other activities requiring appropriate levels of wakefulness until, and unless, treatment with modafinil has been shown to produce levels of wakefulness that permit such activities.
- Caution patient that drug may alter judgment, thinking, or motor skills and to use caution while driving or performing other tasks requiring mental alertness and coordination until tolerance is determined.
- Caution patient that the use of modafinil in combination with alcohol has not been studied, and it is prudent to avoid alcohol while taking modafinil.
- Advise patient to notify health care provider if appetite loss, difficulty sleeping, nervousness, or other bothersome adverse reactions occur.
- Advise patient to stop taking modafinil and immediately notify health care provider if chest pain, mental problems, or rash, hives, or other symptoms of anaphylaxis, angioedema, or other allergic reactions occur.
- Advise women using hormonal contraception (oral, depot, or implantable) to use alternative or concomitant methods of contraception with, and for 1 mo following discontinuation of, therapy.
Generic Name: Modafinil (moe-DAF-i-nill)Provigil is used for: Improving wakefulness in patients with excessive sleepiness associated with narcolepsy or other sleep disorders. It may also be used for other conditions as determined by your doctor.
Provigil is a stimulant drug used to treat unusually sleepy people who have been diagnosed with narcolepsy, obstructive sleep apnea/hypopnea syndrome, or shift work sleep disorder. You should be diagnosed with one of these sleep disorders before taking Provigil, since sleepiness can be a symptom of other medical conditions.
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